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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylpyridine
EC Number:
203-626-4
EC Name:
4-methylpyridine
Cas Number:
108-89-4
Molecular formula:
C6H7N
IUPAC Name:
4-methylpyridine
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material: 4-Methylpyridine

Method

Target gene:
TA 1535 - contains a histidine missense mutation but is also deficient in a DNA repair system (uvr B) and has a defective lipopolysaccharide coat on the cell wall. It is reverted by many agents causing base-pair substitutions, but is not sensitive to frameshift mutagens.

TA 1537 - bears a histidine frameshift mutation. Like TA 1535, it is defective in a DNA repair system and lipopolysaccharide coat. It is sensitive to agents causing frameshift mutations involving insertion or deletion of a single base-pair.

TA 1538 - contains another histidine frameshift mutation. Again it has a defective DNA repair system and lipopolysaccharide coat. It is reverted by agents causing deletion of two adjacent base-pairs (double frameshift mutations).

TA 100 - is the same as TA 1535 but contains a resistance transfer factor conferring ampicillin resistance and increasing sen~itivity to some mutagens (plasmid pKM 101). In addition to base-pair substitutions, it is also able to detect certain frameshift mutagens.

TA 98 - is TA 1538 with the addition of the pKM 101 plasmid. It is reverted by a variety of mutagens, but not by simple alkylating agents causing base-pair substitutions.
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 98, TA 1538, TA 100, TA 1535 and TA 1537
Metabolic activation:
with and without
Metabolic activation system:
Rat S9 activated microsomal fraction
Test concentrations with justification for top dose:
50 to 5000 ug per plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: distilled water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
other: 2-Aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: twice in triplicate

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
Number of revertant colonies

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 98, TA 1538, TA 100, TA 1535 and TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

It was concluded that the test item was devoid of mutagenic activity under the conditions of the test.